What's different about generics

Using generic drugs can be a cost-efficient substitute for brand-name medicines, especially for patients who do not have a prescription plan.

AMY LEAP

Using generic drugs can be a cost-efficient substitute for brand-name medicines, especially for patients who do not have a prescription plan.

However, the look of the pill can vary each time you pick up a refill at the pharmacy or through mail order, which may be confusing.

"Generics are not required to be consistent in color or shape, and that can create problems for a patient on a maintenance regiment," said Dr. Aaron Kesselheim of Brigham and Women's Hospital in Boston, Mass.

The Federal Drug Administration requires generic drugs only to be "bioequivalent," which means they are comparable in dosage to brand-name drugs.

"Only brand-name pharmaceuticals must follow the criteria of color and shape," Kesselheim said.

Generic drugs make up close to 70 percent of the total number of prescriptions filled in the U.S.

A patient could be taking the generic equivalent to the anti-depressant Prozac, which has 10 generics. The patient could possibly "receive different-looking pills every time the prescription is refilled for 10 consecutive refills," said Matthew Grissinger, pharmacist and director of error reporting for the Institute of Safe Medication Practices in Horsham.

"Because patients often rely on the color, size and shape of pills they take every day, when the pill suddenly changes in physical characteristics, they become anxious the medication is wrong and simply stop taking it," Grissinger said.

A recent study published in the New England Journal of Medicine showed a common factor among commercially insured patients who had stopped taking their anti-seizure medication.

"What we discovered was patients taking generic anti-seizure drugs stopped because of the lack of uniformity in shape and color from refill to refill," said Kesselheim, who worked on the study with other researchers at Brigham and Women's Hospital.

When the data from the two preceding prescriptions for each patient was evaluated, researchers learned when the prescription was filled with generic medication, the pills were different in shape or color and sometimes both characteristics had changed.

"Medication nonadherence is a common problem with patients, but this the first time an actual link has been proved," Kesselheim said.

Study results estimated 50 to 70 percent of patients stop taking their prescriptions when the refill doesn't match the previous prescription's shape and color, he said.

Color changes accounted for one out of 400 cases of a patient stopping medication, which may not sound huge at first, but it can add up over time.

"Seniors who typically take nine medications that are each refilled at least four times a year may have 36 opportunities each year to get switched to different-looking pills," Grissinger said.

Patients often rely on the color, size and shape of a pill to keep their drug regiment organized, said Dr. Christian Hermosillo, a pharmacist with St. Luke's University Hospital's HomeStar Pharmacy, Allentown campus.

"They know they take the red at breakfast, the blue one after lunch and the white after dinner, so when the colors change, they often get confused and don't want to ask for help," he said.

Education is key to getting patients to take their prescription correctly.

"Patients need to be taught what their medication looks like, and they need to look at the medicine before they actually leave the pharmacy," Hermosillo said.

Lisa Gill, prescription drug editor for Consumer Reports, agreed and suggested in addition to checking the medicine before leaving the pharmacy, if you are still not satisfied, visit drug.com, where you can look at a photo of the prescription pill in question.

"As a consumer, you also have the right to request your pharmacy obtain your generic prescription drugs from the same manufacturer every time you refill the prescription," she said.

What if the pharmacy is not willing to comply with this request? "Take your prescriptions somewhere else where they are happy to follow your request," Gill said.

A compelling argument can be made that the practice of making generic drugs look different from brand drugs carries a substantial risk, especially to the older population, Grissinger said.

Some pharmacies now place stickers on the prescription bottle to note that a pill has changed in appearance, and recently scientists at the FDA are putting the responsibility back on generic pill manufacturers to consider the study's finding when designing their products.